title: Consistency of return to normal function, productivity, and satisfaction following migraine attacks treated with sumatriptan/naproxen sodium combination.
abstract: OBJECTIVE
  To assess the consistency of improved functioning, productivity, and medication satisfaction in migraines treated with a single tablet of sumatriptan 85 mg/naproxen sodium 500 mg (S/NS) using an early intervention approach.
  
  
  METHODS
  Two randomized, double-blind, placebo-controlled, 4-period crossover, multi-attack, multi-center, outpatient studies of moderate to severe adult migraineurs were conducted to compare S/NS with placebo. Participants recorded outcome assessments in a diary during the 24 hours following study medication. Analyses were conducted on the intent-to-treat population who treated at least 1 attack. Statistical significance between treatment groups used analysis of variance repeated measures models and the intent-to-treat population. There were no corrections for multiplicity.
  
  
  RESULTS
  Almost half (48.5%) of migraineurs treated with S/NS returned to normal functioning at 2 hours and 73.3% at 4 hours postdose, compared with 28.7% (2 hours) and 43.3% (4 hours) of placebo-treated attacks. Total productivity loss over the 24 hours postdose was significantly reduced following S/NS treatment (2.5 hours on average) compared with placebo (4.0 hours). Sumatriptan/naproxen treatment resulted in significantly higher medication satisfaction scores on the efficacy, functionality, and total efficacy subscales compared with placebo in all attacks in both studies. Sumatriptan/naproxen treatment also provided significantly greater ease of use in 7 of the 8 attacks. Although tolerability was high in both treatment groups (over 90%), the placebo group was significantly less bothered by side effects in 6 of 8 attacks.
  
  
  CONCLUSIONS
  Results from these 2 randomized, double-blind, placebo-controlled, multi-attack, crossover studies demonstrated the rapid and consistent restoration of patients' functioning, the consistent reduction in productivity loss, and high satisfaction ratings from patients treating multiple migraine attacks with S/NS using an early intervention approach.
authors.affiliation: Wesley Neurology Clinic, Memphis, TN, USA.
authors.forename: Stephen H
authors.initials: SH
authors.lastname: Landy
authors.forename: Roger K
authors.initials: RK
authors.lastname: Cady
authors.forename: Andrew
authors.initials: A
authors.lastname: Nelsen
authors.forename: Jonathan
authors.initials: J
authors.lastname: White
authors.forename: M Chris
authors.initials: MC
authors.lastname: Runken
mesh_terms: D000328:Adult; D000700:Analgesics / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D009288:Naproxen / Q000008:administration & dosage*; D017060:Patient Satisfaction; D018170:Sumatriptan / Q000008:administration & dosage*
chemical_list: D000700:Analgesics; D004338:Drug Combinations; D009288:Naproxen; D018170:Sumatriptan
keywords: consistency of treatment response; functioning; migraine; productivity; satisfaction; sumatriptan/naproxen sodium